Tag Archive for: Associated Press

FDA plans modest changes to medical device system

Associated Press (Link to Article)
WASHINGTON – The Food and Drug Administration is laying out plans to update the 35-year-old system used to approve most medical devices, which has been subject to increasing criticism by public safety advocates.
The agency announced a series of changes it plans to make this year, including streamlining the review process for some low-risk devices. But regulators said they will delay a decision on the most drastic proposals, which would give the government new power to police device makers.
Those proposals, widely supported by public safety advocates, included clarifying the FDA’s power to revoke approval for products that prove unsafe or ineffective. Another key proposal would have established a new subset of devices that would require more medical data to gain approval.
But those proposals, unveiled for comment last summer, received strong pushback from device companies, and the FDA said in its report “that implementing them may be problematic.”
The device industry’s chief trade group, AdvaMed, lobbied against the changes, saying they would make device reviews longer and more expensive, hurting innovation and endangering jobs. The group represents most of the largest device firms, including Medtronic Inc., Stryker Corp. and Johnson & Johnson.
AdvaMed’s president Stephen Ubl called Wednesday’s announcement “a good first step that will address some of the major problems with the program.”
But Dr. Diana Zuckerman of the National Research Center for Women and Families said the FDA’s plan suggests “industry lobbyists won, and the public lost.”
“Today’s FDA report gives the impression that FDA backed down on several safeguards as a result of unfavorable comments,” Zuckerman said in a statement. “FDA decisions should not be based on a popularity contest, especially since lobbyists rig the results”
The FDA said it would wait for the guidance of the Institute of Medicine before making a final decision on more sweeping changes. The group, which advises the federal government on medical issues, is expected to make its recommendations this summer.
The so-called 510(k) system for devices was created in 1976 to grant speedy approval to devices that are similar to products already on the market. It is popular among manufacturers because it is a faster, cheaper path to market than the review process for novel devices, which must undergo rigorous medical testing. Hip replacements and drug pumps are among the devices cleared under the system.
But FDA critics say that high-risk devices, such as heart pacemakers, are increasingly slipping through the 510(k) process without thorough testing and scrutiny.
About 4,000 devices are cleared every year under the 510(k) system, while about 50 devices are approved under the more stringent system.
Last October the FDA took the unprecedented step of acknowledging that a knee repair device cleared via 510(k) in 2008 should not have made it to market. The FDA’s two top device regulators who oversaw the device’s review have since left the agency.
Beginning in March the FDA said it will make 25 changes to the 510(k) process, including:
• establishing a database with photos and safety labeling for all devices
• clarifying when companies must submit clinical data for a 510(k) application
• establishing a council of experts within the agency to work on timely device approvals
Medical device executives praised the FDA for not significantly altering the system for approving their products.
“The fact that they are not going to take on more than they should right now, and deferring some of the tougher proposed changes to the appropriate guidance process, was a constructive outcome,” said Bill Hawkins, chief executive of Medtronic, the world’s largest medical device company.

Technology A Blessing, A Curse For Remote Island by THE ASSOCIATED PRESS

Technology A Blessing, A Curse For Remote Island
by Martha Irvine, Associated Press national writer.

BEAVER ISLAND, Mich. November 8, 2010, 12:14 pm ET
Muggs Bass doesn’t own a computer. She’s pretty much dead set against e-mail. Anyone who calls her home on Michigan’s remote Beaver Island should be prepared for a busy signal, if she’s on her land-line phone. She has no cell.

“When you don’t have it, you don’t miss it. That’s what I say,” says the spunky 70-year-old grandmother, who’s as comfortable telling jokes at the local pub as she is attending Mass each morning.

Technology isn’t really her thing. So, it’s a small miracle when Bass drives, once a month, to her island’s rural health center to sit down in front of a wide-screen television. There, she and a handful of other islanders connect by video conference with a similar group in Charlevoix, Mich., a two-hour ferry ride to the south and east.

They chat. They laugh. They cry together.

All of them have, or have had, cancer, Bass included. Hers started with a lump in her breast and has since metastasized to her bones, making her cancer treatable, but incurable, her doctors tell her.

Her own grandmother died of the same disease and went off the island for occasional treatments, as Bass does every few weeks. But that grandmother could hardly have imagined a day when islanders talked openly about their cancer, face-to-face with people in a support group miles away.

It’s just one of many ways technology is making this rugged place less remote than it once was and, some would say, more livable for more people.

It also gives islanders hope for new jobs that could attract residents to this island in northern Lake Michigan where the year-round population is about 650 people, give or take a few dozen.

“In the last few years, technology has sprung,” says Joe Moore, a retired teacher who’s known as one of the geeks on the island who helps keep computers running.

Not that the change has come quickly, or that technology always works perfectly.

That’s just how it is on an island where a popular bumper sticker reads “Slow Down! This Ain’t The Mainland.” It’s aimed at anyone who’s in too big a hurry, including lead-footed tourists who kick up dust on the many dirt roads or who panic when cell phone service drops.

That’s life on wired — or at least, semi-wired — Beaver Island… (continued)


I think this is a Great article – I love hearing positive tech success stories & how it’s used to connect with loved ones as well as communicate with remote care providers. This is the way technology should be used. Certainly, like with anything, it can be over-used and abused. Thinking about the island visitors who freak when cell reception goes dead finds me feeling a bit sheepish – perhaps we ALL could use a little more of the Beaver Island attitude. What really is important is that with tech today, all age groups can CONNECT & benefit! Muggs discusses that she doesn’t really care to use tech & while that may partly be true (no cell or PC), she really IS using technology every day. Using web chat (via skype) an I would guess that much of her medical care utilizes cutting-edge tech as well. At GrandCare Systems, we do the same thing. Smarthome Tech, Activity of Daily Living monitoring, Telehealth, Remote Socialization Tech to individuals who want to stay independent & connected to family. Similarly, GrandCare allows a loved one to Skype with ONE touch on the interactive touchpad. The loved one doesn’t have to know anything about computers to use it – perfect for beaver island! Thanks again! Laura Mitchell, GrandCare Systems